Introduction :

Introduction The use of legally available drugs is the Good Medical Practice that all patients hope.
If a medicinal is used for an indication which is not stated in the labeling , they’ll be responsible for:
Well informed about the product
Base its use on firm scientific rational
Sound medical evidence
Maintain records of the product’s use and effects1 Bernard Fallon. Off label drug use in sexual medicine. Int J Impot Resc. 20(2):127-134,2008
1-US food and drug administration FDA. Off label and investigational use of marketed drugs, biologics and medical devices.

Introduction :

Introduction FDA allows the off-label use of medicines in the medical practice without IRB review.1
“Off-label” use often means that efficacy, safety and tolerability data are not available for that specific use:
Classes commonly used:
Anticonvulsants
Antipsychotics
Antihistamines
Antiasthmatics
Cardiovascular agents Bernard Fallon. Off label drug use in sexual medicine. Int J Impot Resc. 20(2):127-134,2008
1-US food and drug administration FDA. Off label and investigational use of marketed drugs, biologics and medical devices.

Introduction :

Introduction According to one study, approximately 21% of all prescriptions are written for off-label indications in office practice, and approximately 73% of those off-label uses have little or no scientific support.1
The great majority of drug use in pediatric practice is off-label, as therapeutic trials are rarely conducted in pediatric patients.
Likewise, drug treatment in oncology and HIV treatment is commonly off-label. US food and drug administration FDA. Off label and investigational use of marketed drugs, biologics and medical devices.
1-Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med; 166: 1021—1026,2006.

Drug manufacturers will not usually try to get FDA approval for off-label uses of their products because of the time and expense involved, and may be subject to legal action by the FDA if they market products for off-label uses.1 :

Drug manufacturers will not usually try to get FDA approval for off-label uses of their products because of the time and expense involved, and may be subject to legal action by the FDA if they market products for off-label uses.1 1-Henry V. Off-label prescribing: legal implications. J Leg Med. 20: 365—384; 1999.

Slide 6:

Of all drugs, commonly used in the treatment of sexual dysfunctions,
phosphodiesterase type 5 inhibitors (PDE5 inhibitors) are FDA-approved for treatment of male erectile dysfunction, and
Testosterone is approved for the treatment of delayed puberty and hypogonadism in men.
All other drug usage in the treatment of sexual dysfunctions is off-label, some with good evidence of efficacy, and some without. Bernard Fallon. Off label drug use in sexual medicine. Int J Impot Resc. 20(2):127-134,2008

Dapoxetine (PriligyTM) :

Dapoxetine (PriligyTM) 10th of Feb. 2009 received the first regulatory approval in Finland and Sweden.
Now its approved in 7 European countries (EMEA).
FDA approval is still bending for more studies as asked in 2006.

Commonly used drugs in SD :

Commonly used drugs in SD

Slide 10:

According to the Theme of the Conference, I will elaborate on the off label drug use of:
Premature ejaculation (PME).
Peyronie’s disease(PD).

Serotonergic control of ejaculation :

Serotonergic control of ejaculation 5-HT neurotransmission is locally regulated by the 5-HT transporter re-uptake system
As 5-HT is released, the transporter system is activated, removing 5-HT from the synaptic cleft and preventing over-stimulation of postsynaptic 5-HT receptors McMahon CG et al, Disorders of orgasm and ejaculation in men. In Sexual Medicine:
Sexual dysfunctions in men and women. 2nd International Consultation on Sexual Dysfunctions, Paris, 2004

Slide 32:

Summary :

Summary Off-label use of drugs is common in treating sexual disorders.
It is reasonable to recommend the routine use of a particular treatment if there is high-level evidence of efficacy and safety.
The quality of the evidence should be high-level 1 or 2, using the Oxford Center for Evidence-Based Medicine criteria
The use of SSRIs (with daily dosing) in PE seems to have a reasonable evidence-based justification.
None of the treatments for PD has evidence-based justification, as there are essentially no randomized controlled trials.